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The physical inactivity promoted by the patient's hospitalization, including those infected with the coronavirus, can lead to an important health impairment, including atrophy and loss of muscle function. Thus, a prospective study will be conducted to assess the effect of a home-based exercise training program on health outcomes and quality of life in COVID-19 survivors.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Exercise group | Experimental |
| |
| Control group | No Intervention | The control group will receive all regular medical care and advice on healthy lifestyle including the promotion of recommended physical activity levels. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Exercise training | Other | A 16 weeks parallel-group randomised controlled trial will be performed, in which covid-19 survivors patients will complete a telemonitored home-based exercise training program, 3 times per week. The training program will involve strength, aerobic, balance and flexibility exercises. |
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline on quality of life assessed by the SF-36 health survey questionnaire at 16 weeks. | Higher score means better outcome. | Baseline and 16 weeks. |
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline on fatigue evaluated by the fatigue severity scale at 16 weeks. | Higher score means worse outcome. | Baseline and 16 weeks. |
| Change from baseline on lipid profile at 16 weeks. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Bruno Gualano, PhD | Contact | 55112661 | 8021 | gualano@usp.br |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Sao Paulo | Recruiting | São Paulo | 05508-030 | Brazil |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37164620 | Derived | Longobardi I, Goessler K, de Oliveira Junior GN, Prado DMLD, Santos JVP, Meletti MM, de Andrade DCO, Gil S, Boza JASO, Lima FR, Gualano B, Roschel H. Effects of a 16-week home-based exercise training programme on health-related quality of life, functional capacity, and persistent symptoms in survivors of severe/critical COVID-19: a randomised controlled trial. Br J Sports Med. 2023 Oct;57(20):1295-1303. doi: 10.1136/bjsports-2022-106681. Epub 2023 May 10. |
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| ID | Term |
|---|---|
| D000086382 | COVID-19 |
| D045169 | Severe Acute Respiratory Syndrome |
| ID | Term |
|---|---|
| D011024 | Pneumonia, Viral |
| D011014 | Pneumonia |
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
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| ID | Term |
|---|---|
| D015444 | Exercise |
| ID | Term |
|---|---|
| D009043 | Motor Activity |
| D009068 | Movement |
| D009142 | Musculoskeletal Physiological Phenomena |
| D055687 | Musculoskeletal and Neural Physiological Phenomena |
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|
Total cholesterol, HDL cholesterol, LDL cholesterol, triglycerides
| Baseline and 16 weeks. |
| Change from baseline on insulin sensitivity at 16 weeks. | Fasting serum concentrations of glucose and insulin. | Baseline and 16 weeks. |
| Change from baseline on inflammatory cytokine IL-1 at 16 weeks. | Baseline and 16 weeks. |
| Change from baseline on inflammatory cytokine IL-1ra at 16 weeks. | Baseline and 16 weeks. |
| Change from baseline on inflammatory cytokine IL-6 at 16 weeks. | Baseline and 16 weeks. |
| Change from baseline on inflammatory cytokine IL-10 at 16 weeks. | Baseline and 16 weeks. |
| Change from baseline on inflammatory cytokine TNF-alpha at 16 weeks. | Baseline and 16 weeks. |
| Change from baseline on C-reactive Protein at 16 weeks. | Baseline and 16 weeks. |
| Change from baseline on Creatine Kinase at 16 weeks. | Baseline and 16 weeks. |
| Change from baseline on cardiopulmonary fitness assessed by a maximal exercise test at 16 weeks. | Baseline and 16 weeks. |
| Change from baseline on lean body mass assessed by Dual-energy absorptiometry at 16 weeks. | Baseline and 16 weeks. |
| Change from baseline body fat assessed by Dual-energy absorptiometry at 16 weeks. | Baseline and 16 weeks. |
| Change from baseline on waist circumference at 16 weeks. | Baseline and 16 weeks. |
| Change from baseline on hip circumference at 16 weeks. | Baseline and 16 weeks. |
| Change from baseline on body weight at 16 weeks. | Baseline and 16 weeks. |
| Change from baseline on muscular strength assessed by handgrip test at 16 weeks. | Baseline and 16 weeks. |
| Change from baseline on muscular function assessed by Timed-Stand Test at 16 weesks. | Baseline and 16 weeks. |
| Change from baseline on muscular function assessed by Timed-Up and Go Test at 16 weeks. | Baseline and 16 weeks. |
| Change from baseline on anxiety symptoms assessed by Back Scale at 16 weeks. | Higher score means worse outcome. | Baseline and 16 weeks. |
| Change from baseline on depression symptoms assessed by Back Scale at 16 weeks. | Higher score means worse outcome. | Baseline and 16 weeks. |
| Change from baseline on functional status assessed by Post-COVID-19 Functional Status (PCFS) Scale at 16 weeks. | Higher score means worse outcome. | Baseline and 16 weeks. |
| Change from baseline on physical activity levels evaluated by the International Physical Activity Questionnaire at 16 weeks. | Baseline and 16 weeks. |
| Change from baseline on resting blood pressure assessed by an automated device at 16 weeks. | Baseline and 16 weeks. |
| Change from baseline on fatigue assessed by Chalder scale at 16 weeks. | Higher score means worse outcome. | Baseline and 16 weeks. |
| Change from baseline on heart rate variability assessed by heart rate monitor at 16 weeks. | Baseline and 16 weeks. |
| Change from baseline on inspiratory muscular strength assessed by power breathe at 16 weeks. | Baseline and 16 weeks. |
| Change from baseline on quality of life assessed by the SF-36 health survey questionnaire at one year. | Higher score means better outcome. | Baseline and one year. |
| Change from baseline on fatigue evaluated by the fatigue severity scale at one year. | Higher score means worse outcome. | Baseline and one year. |
| Change from baseline on fatigue assessed by Chalder scale at one year. | Higher score means worse outcome. | Baseline and one year. |
| Change from baseline on functional status assessed by Post-COVID-19 Functional Status (PCFS) Scale at one year. | Higher score means worse outcome. | Baseline and one year. |
| Change from baseline on muscular function assessed by Timed-Up and Go Test at one year. | Baseline and one year. |
| Change from baseline on muscular function assessed by Timed-Stand Test at one year. | Baseline and one year. |
| Change from baseline on muscular strength assessed by handgrip test at one year. | Baseline and one year. |
| Change from baseline on cardiopulmonary fitness assessed by a maximal exercise test at one year. | Baseline and one year. |
| D014777 |
| Virus Diseases |
| D018352 | Coronavirus Infections |
| D003333 | Coronaviridae Infections |
| D030341 | Nidovirales Infections |
| D012327 | RNA Virus Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |